Blood Changes After Exercise in Restless Legs Syndrome

NCT ID: NCT06481176

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this clinical trial is to learn how exercise changes molecules in the blood in people with restless legs syndrome (RLS) to better understand the cause(s) of RLS. The main questions the investigators aim to answer are:

How does long-term exercise change proteins in the blood?

How does a single exercise session change proteins in the blood?

The investigators will compare long-term exercise to no exercise to see if the changes in proteins are specific to exercise.

Participants will complete an exercise test and provide blood samples before and after the exercise test. Participants will be randomized (like the flip of a coin) in to either the exercise or no-exercise group for 12 weeks and then complete the exercise test and blood samples again at the end.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

Participants will complete a 12-week, RLS specific exercise program including strength training, cardiovascular exercise, and stretching.

Group Type: EXPERIMENTAL

12-Week RLS Exercise Program

Intervention Type: BEHAVIORAL

Participants will complete 12 weeks of an evidence-based exercise program that has been used for people with RLS, designed for people with RLS, and was informed by exercise guidelines outlined by the American College of Sports Medicine (ACSM) and the American Heart Association, and Center for Disease Control.

The program includes three sessions per week for 12 weeks including:

• cardiovascular exercise (e.g., walking/jogging, bicycling) for 30 minutes/day on at least 3 days/week at a moderate-to-vigorous intensity
• strength training on 2 non-consecutive days/week targeting major muscle groups for approximately 30 minutes
• Stretching all major muscle groups on three or more days per week

Non-Exercise

Participants will have no intervention or interaction for 12 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

12-Week RLS Exercise Program

Participants will complete 12 weeks of an evidence-based exercise program that has been used for people with RLS, designed for people with RLS, and was informed by exercise guidelines outlined by the American College of Sports Medicine (ACSM) and the American Heart Association, and Center for Disease Control.

The program includes three sessions per week for 12 weeks including:

• cardiovascular exercise (e.g., walking/jogging, bicycling) for 30 minutes/day on at least 3 days/week at a moderate-to-vigorous intensity
• strength training on 2 non-consecutive days/week targeting major muscle groups for approximately 30 minutes
• Stretching all major muscle groups on three or more days per week

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 18 years or older;
• diagnosis of RLS;
• presence of moderate-to-severe RLS (IRLS score>15);
• currently untreated RLS;
• being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months;
• ability to walk without assistance (does not use a cane/walker/wheelchair for mobility;
• willing to complete outcome measures and complete the exercise program

Exclusion Criteria

• present with a condition that can mimic RLS or cause secondary RLS (e.g., iron deficiency anemia, radiculopathy, peripheral edema, peripheral neuropathy, diabetes);
• are at moderate or high risk for undertaking strenuous or maximal exercise

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Emmanuel Mignot

Craig Reynolds Professor of Sleep Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emmanuel Mignot, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katie Cederberg, PhD

Role: CONTACT

kcederb@stanford.edu

(650) 725-6517

Facility Contacts

Katie Cederberg, PhD

Role: primary

RLSresearch@stanford.edu

650-725-6517

Other Identifiers

75422

Identifier Type: -

Identifier Source: org_study_id